FDA Warns Injectable Drug Can Cause Gangrene

Promethazine can cause tissue injuries when used incorrectly

NEW YORK - The Food and Drug Administration said Tuesday makers of the antihistamine and anti-nausea drug promethazine have to warn consumers over the potential risk of tissue injuries including gangrene if the injectable drug is administered incorrectly.

The FDA is requiring companies to include a warning on the drug's label to state that it should not be administered into an artery or under the skin because of the risk. There is also a risk that the drug can leach out from the vein during intravenous administration and cause serious damage to the surrounding tissue, the agency said.

The drug should be injected deep into a muscle.

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